Regulatory and Legal
Aug 23, 2016
Marie Thibault ImPACT and ImPACT Pediatric have been FDA-cleared for use in assessing a person's cognitive function after a suspected concussion or brain...
Aug 18, 2016
Marie Thibault FDA has approved Edwards Lifesciences' Sapien 3 THV for use in intermediate-risk aortic stenosis patients. FDA has approved the Sapien 3...
Aug 11, 2016
Marie Thibault After much deliberation and years of waiting, FDA this week released two draft guidances on when a modification warrants a new 510(k)...
Aug 10, 2016
Marie Thibault The FDA approval covers MR-conditional labeling for Emblem S-ICD systems that have already been implanted. This week, FDA granted regulatory...
Aug 03, 2016
Marie Thibault Endologix's Nellix EndoVascular Aneurysm Sealing (EVAS) system, is a hotly anticipated device for which patients and clinicians may...
Aug 02, 2016
Marie Thibault ReliantHeart's aVAD intraventricular left ventricular assist device has received CE Mark. ReliantHeart’s new left ventricular assist device (...
Jul 22, 2016
Marie Thibault Dexcom wants U.S. patients to be able to use its G5 Mobile Continuous Glucose Monitoring system to make insulin dosing and treatment decisions...
Jul 19, 2016
Marie Thibault The push to add implantable medical device unique device identifiers (UDIs) to insurance claims forms is gathering steam. The effort has been...
Jul 12, 2016
Marie Thibault The reimbursement process for healthcare technology can be confusing even for experts and industry insiders. That has troubled legislators,...
Jul 05, 2016
Marie Thibault Abbott's Absorb GT1 Bioresorbable Vascular Scaffold System is the first U.S.-approved fully-dissolving coronary stent. Absorb, Abbott's...